Regulatory overview and development of business model for autologous T cell cancer treatment
|Coordinator||TCER AB - Center for Molecular Medicine|
|Funding from Vinnova||SEK 300 000|
|Project duration||October 2017 - February 2018|
Purpose and goal
We have developed a new concept called A-STAR, for generation of next-generation biologics, based on T-cells. The purpose of the present project was to map the regulatory framework of our medical procedure and develop a suitable business model
Expected results and effects
We have developed a regulatory road map for our product. In addition, we have established the basis for a business model for personalized T-cell transfusion in the treatment of cancer. Understanding of the regulatory landscape and development of business models are crucial activities that will govern future funding needed to reach the market.
Planned approach and implementation
TCER AB is based on more than 20 years of research. The work of mapping the regulatory framework has been carried out together with world-leading clinical immunologists in close cooperation with the CRO Scandinavian Development System. Establishing a credible business plan and economic analysis has been done in cooperation with an external international highly experienced business developer.